The present invention relates to a urinary incontinence device and a method of using the same. More specifically, this invention relates to a molar-shaped device for alleviating female urinary incontinence, particularly during episodes of increased intra-abdominal pressure.
The primary etiological factor producing genuine stress urinary incontinence is the incomplete transmission of abdominal pressure to the proximal urethra due to displacement from its intra-abdominal position. Some women, especially women who have given birth to one or more children, and older women, can experience incidences of involuntary urine loss due to stress urinary incontinence or combined stress and urge incontinence. A sneeze or cough increases the intra-abdominal pressure which in turn increases the pressure on a person""s bladder causing the involuntary release of urine. The frequency and severity of such urine loss can increase as the muscles and tissues near the urethro-vaginal myofascial area grow weaker. It has also been recognized that the urinary sphincter muscle, which is located at the upper end of the urethra, adjacent to the bladder, works well at sealing off the passing of urine from the bladder to the urethra when it has a round or circular cross-sectional configuration.
Support of the proximal urethra elevates it above the pelvic floor and subjects it to increases in intra-abdominal pressure, thus allowing compression and maintenance of continence. When this passageway becomes distorted into a cross-sectional configuration having more of an elliptical or oval appearance, however, the sphincter muscle can not close properly. Therefore, the tendency for involuntary urine loss increases. One must remember that the urethra and vagina are not separate structures. Because of their common derivation from the urogenital sinus, they are fused in the distal two-thirds of the urethra. In this region they are bound together by the endopelvic connective tissue so that the support of the urethra depends not only on the attachments of the urethra itself to adjacent structures but also on the connection of the vagina and periurethral tissues to the pelvic wall.
As the world""s female population ages, there is an ever-increasing need for a non-surgical method or measure to reduce the involuntary urine loss commonly associated with stress urinary incontinence. Although there are specialized products available for this purpose, most can only be purchased with a prescription and they need to be properly sized, physically inserted and/or adjusted by a medical doctor for them to correctly perform.
In view of the lack of non-prescription, commercially available devices, there is a need for a urinary incontinence device that can be purchased by the consumer and that is uncomplicated and user friendly. Furthermore, there is a need for a urinary incontinence device that is easy for a woman to insert into and remove from their body that is more comfortable to wear and to provide psychological and realistic assurance that it is capable of properly performing over an extended period of time.
The present invention relates to an intra-vaginal urinary incontinence device that is a molar-shaped resilient insert. The insert may also have a pear shape, tear drop shape, and/or an obconical shape. The insert has a top and a bottom with the cross sectional area of the top being larger than the cross sectional area of the bottom. In use, at least a portion of the top respectively contacts at least the anterior and posterior vaginal walls and may also simultaneously contact the left and right vaginal walls to restore the retropubic position of the bladder neck.
The top of the insert is provided with a top surface that may be closed or may be provided with an aperture. Likewise, the bottom of the insert may be closed or may be provided with an aperture. When an aperture is present on the top surface, an aperture is provided on the bottom surface and the aperture on the top surface communicates with the aperture provided on the bottom surface to allow fluids to pass through the insert. In one embodiment, a channel is provided to connect the aperture provided on the top surface with the aperture provided on the bottom surface.
In a particular embodiment, the top surface of the insert includes at least one cusp that extends upward from the top surface to define an area of greater resistance to deformation as compared to an area that does not contain a cusp. The top surface may include at least two opposed cusps and, in one embodiment, may include three cusps in a triangular formation. Alternatively, the top surface may include four cusps, with each cusp being both diagonally and laterally opposed to another cusp. In this embodiment, the aperture may be centrally located between each cusp.
In use, the area adjacent the at least two opposed cusps will contact the anterior and posterior vaginal walls such that the urethra will rest in the area between the cusps. As a result, the bladder neck will be restored to a more normal retropubic position and the urethra will be properly aligned with the bladder neck thereby restoring continence.
The insert may also be provided with a removal member that cooperates with the insert to allow the insert to be removed from the vagina. The removal member may be separate from or integral with the insert. Accordingly, in one embodiment, the removal member is attached to at least a portion of the bottom of the insert. In another embodiment, the removal member is attached to the channel that connects the top and bottom apertures.
The insert may be formed from a variety of biocompatible materials and may be formed as a solid or semi-solid mass of a compressible, resilient, biocompatible material. Alternatively, the insert may be formed such that the insert has a thin wall that defines an outer surface and an inner surface. In this embodiment, the inner surface defines an interior of the insert. The interior may contain a resilient material that allows the wall of the insert to deform and conform to the shape of the object acting to deform the wall such as one or more of the vaginal walls.
Put another way, the device of the present invention is an intra-vaginal device that can simultaneously engage the anterior vaginal wall and the posterior vaginal wall, or each of the anterior vaginal wall, the posterior vaginal wall, the left vaginal wall and the right vaginal wall. The cusps provide anatomical realignment of the urethra and sphincter muscles to restore the retropubic position of the bladder neck so intra-abdominal pressure is once again transmitted equally to the bladder and urethra. The device is formed of a resilient material so that, in use, it may be resiliently deformed to conform to the shape of the vaginal walls.
The present invention also includes a method of alleviating female urinary incontinence by providing a female urinary incontinence device as described above and in the specification below, selectively inserting the device into a woman""s vagina so that the device simultaneously contacts or the anterior vaginal wall and the posterior vaginal wall or all the walls in the bladder neck region to restore the retropubic position of the bladder neck.
Advantageously, the device and method of present invention provides for control of female urinary incontinence by use of a device that does not create undue friction or distension of the mucosal tissue and yet allows for normal discharge of vaginal secretions.